Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
Sub-study of SPYRAL AFFIRM: Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT)
Medtronic Vascular
130 participants
Sep 22, 2025
INTERVENTIONAL
Conditions
Summary
The purpose of the SPYRAL SWYFT sub-study is to evaluate whether renal denervation with the Symplicity Spyral system performed in the main and first order branch renal arteries yields a shorter procedure time and is as effective in reducing blood pressure than the procedural approach used in the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED clinical studies in an uncontrolled hypertensive population.
Eligibility
Inclusion Criteria4
- Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
- Individual has a baseline office diastolic blood pressure ≥ 90 mmHg
- Individual has an average systolic baseline home blood pressure ≥135 mmHg (with ≥7 days of valid pre-procedure measurements)
- Individual has a valid 24-hour Ambulatory Blood Pressure Measurement at baseline
Exclusion Criteria9
- Individual lacks appropriate renal artery anatomy
- Individual has undergone prior renal denervation
- Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
- Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
- Individual has an estimated glomerular filtration rate (eGFR) of \<45 mL/min/1.73m2
- Individual has one or more episode(s) of orthostatic hypotension
- Individual is pregnant, nursing or planning to become pregnant
- Individual has documented primary pulmonary hypertension
- Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%
Interventions
After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.
Locations(19)
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NCT07115953